CYCLO-PROGYNOVA 2MG

Transcript

1.

What Cyclo-Progynova is for

Cyclo-Progynova belongs to a group of medicines
called hormone replacement therapy (HRT).
Cyclo-Progynova contains two hormones
called estradiol (an oestrogen) and norgestrel (a
progestogen). These act in different ways in your
body.
During the menopause (sometimes called “the
change of life”) a woman’s body slowly produces
less oestrogen. This may cause hot flushes, night
sweats, mood swings and dryness in the vagina.
Over a long time it may also cause a thinning of
the bones, which may be more likely to then break
(osteoporosis).
Cyclo-Progynova works by replacing the
oestrogen you lose during the menopause and
therefore improves the unpleasant symptoms you
may get. Oestrogen can also make the lining of
your womb grow more than usual, which may lead
to cancer developing there. The other hormone in
Cyclo-Progynova called a progestogen reduces
the chance of getting cancer of the womb.

1.1 Cyclo-Progynova is used for:
• Treating symptoms of the menopause. This
includes hot flushes, night sweats, mood swings
and dryness in the vagina
• Preventing thinning of the bones (osteoporosis)
in women who are not allowed to take other
types of medicines to prevent this from
happening
There are some small risks with taking HRT and
you should discuss this with your doctor before
you start taking Cyclo-Progynova (also see
Section 2).

2.

Before you take Cyclo-Progynova

2.1 Do not take Cyclo-Progynova if you
have, or have ever had:
• An allergic reaction to estradiol or norgestrel
• An allergic reaction to any of the other
ingredients of Cyclo-Progynova (listed in
section 6)
• Breast or womb cancer
• Bleeding from your vagina and the cause is not
known
• Endometrial hyperplasia that is not being treated
(an overgrowth of the lining of the womb)
• Blood clots in a vein in your leg (deep vein
thrombosis or DVT) or in your lungs (pulmonary
embolus) or any other problems with blood clots
forming.
• if you have a high risk of venous or arterial
thrombosis (blood clot)
• Angina, a stroke or other heart disease
• Liver problems
• Kidney problems
• Porphyria (a rare blood disorder).
If any of the above applies to you, do not take
Cyclo-Progynova and talk to your doctor or
pharmacist.

2.2 Check with your doctor before taking
Cyclo-Progynova if you have, or have
ever had any of the following:
• Uterine fibroids (lumps of fibrous and muscular
tissue in your womb)
• Endometriosis (where tissue from the womb is
found outside the womb)
• Endometrial hyperplasia (overgrowth of the
lining of the womb)
• Risk factors for cancer, such as history of the
disease in your family
• Risk factors for blood clotting problems
• Risk factors for angina, a stroke or heart disease
• You have elevated levels of triglycerides (special
type of blood lipids)
• chloasma (patches of discoloration on the skin)
• High blood pressure
• Diabetes
• Gallstones
• Adenoma of the anterior lobe of the pituitary
gland (pituitary adenoma)
• Migraine or severe headache
• Systemic lupus erythematosus, (SLE or lupus
for short)
• Epilepsy
• Asthma
• Otosclerosis (hearing loss due to a problem with
the bones in the ear).
• A condition known as hereditary angioedema
(see section 4).
• Chorea minor
• Premature menopause

2.3 Safety of HRT
As well as benefits, HRT has some risks which
you may wish to discuss with your doctor
when you are deciding whether to start HRT, or
whether to carry on taking it.
Effects on your heart or circulation

2.4 Heart disease
HRT is not recommended for women who
have or have recently had heart disease. If you
have ever had heart disease, talk to your doctor
to see if you should be taking HRT.
HRT will not help to prevent heart disease.
Studies with one type of HRT (containing
conjugated oestrogen plus the progestogen
MPA) have shown that women may be slightly
more likely to get heart disease during the first
year of taking the medication. For other types of
HRT, the risk is likely to be similar, although this
is not yet certain.

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Bayer Pharma AG
code-no.: 666
country: GB/-/MEDA

If you get:
A pain in your chest that spreads to your arm
or neck.
See a doctor as soon as possible and do not
take any more HRT until your doctor says you
can. This pain could be a sign of heart disease.

2.5 Stroke
Recent research suggests that HRT slightly
increases the risk of having a stroke. Other
things that can increase the risk of stroke
include:
• Getting older
• High blood pressure
• Smoking
• Drinking too much alcohol
• An irregular heartbeat.
If you are worried about any of these things,
or if you have had a stroke in the past, talk to
your doctor to see if you should take HRT.
Compare:
• Looking at women in their 50s who are not
taking HRT — on average, over a 5-year
period, 3 in 1000 would be expected to have
a stroke.
• For women in their 50s who are taking HRT,
the figure would be 4 in 1000.
• Looking at women in their 60s who are not
taking HRT — on average, over a 5-year
period, 11 in 1000 would be expected to have
a stroke.
• For women in their 60s who are taking HRT,
the figure would be 15 in 1000.
If you get:
Unexplained migraine-type headaches, with
or without disturbed vision.
See a doctor as soon as possible and do not
take any more HRT until your doctor says you
can. These headaches may be an early warning
sign of a stroke.

2.6 Blood clots
HRT may increase the risk of blood clots in the
veins (also called deep vein thrombosis, or
DVT), especially during the first year of taking it.
These blood clots are not always serious, but
if one travels to the lungs, it can cause chest
pain, breathlessness, collapse or even death.
This condition is called pulmonary embolism,
or PE.
DVT and PE are examples of a condition called
venous thromboembolism, or VTE.
You are more likely to get a blood clot if:
• You are seriously overweight
• You have had a blood clot before
• Any of your close family have had blood clots
• You have had one or more miscarriages
• You have any blood clotting problem that
needs treatment with a medicine such as
warfarin
• You’re off your feet for a long time because of
major surgery, injury or illness
• You have a rare condition called SLE (see
Section 2).
If any of these things apply to you, talk to
your doctor to see if you should take HRT. Your
doctor will discuss with you the benefits and
risks of Cyclo-Progynova. She/he will check,
e.g. whether you have a higher risk of getting a
thrombosis due to a combination of risk factors
or perhaps one very strong risk factor. In the
case of a combination of factors the risk may be
higher than simply adding two individual risks. If
the risk is too high, your doctor will not prescribe
HRT treatment.
Compare:
• Looking at women in their 50s who are not
taking HRT — on average, over a 5-year
period, 3 in 1000 would be expected to get a
blood clot.
• For women in their 50s who are taking HRT,
the figure would be 7 in 1000.
• Looking at women in their 60s who are not
taking HRT — on average, over a 5-year
period, 8 in 1000 would be expected to get a
blood clot.
• For women in their 60s who are taking HRT,
the figure would be 17 in 1000.
If you get:
• painful swelling in your leg
• sudden chest pain
• difficulty breathing.
You must see a doctor as soon as possible
and do not take any more HRT until your
doctor says you can. These may be signs of a
blood clot

2.7 Surgery (Surgical operations)
If you’re going to have surgery, make sure
your doctor knows about it. You may need to
stop taking HRT about 4 to 6 weeks before the
operation, to reduce the risk of a blood clot. Your
doctor will tell you when you can start taking
HRT again.
Effects on your risk of developing cancer

2.8 Breast cancer
Women who have breast cancer, or have had
breast cancer in the past, should not take
HRT.
Taking HRT slightly increases the risk of breast
cancer; so does having a later menopause,
alcohol intake and adiposity. The risk for a postmenopausal woman taking oestrogen-only HRT
for 5 years is about the same as for a woman of
the same age who is still having periods over that
time and not taking HRT. The risk for a woman
who is taking oestrogen plus progestogen HRT
is higher than for oestrogen-only HRT (but
oestrogen plus progestogen HRT is beneficial
for the endometrium, see ‘Endometrial cancer’
below).
For all kinds of HRT, the extra risk of breast
cancer goes up the longer you take it, but returns
to normal within about 5 years after stopping
HRT.
Your risk of breast cancer is also higher if you:
• Have a close relative (mother, sister or
grandmother) who has had breast cancer
• are seriously overweight.
Compare:
• Looking at women aged 50 who are not
taking HRT — on average, 32 in 1000 will be
diagnosed with breast cancer by the time they
reach the age of 65.
• For women who start taking oestrogen-only
HRT at age 50 and take it for 5 years, the
figure will be 33 and 34 in 1000 (i.e. an extra
1-2 cases).
• If they take oestrogen-only HRT for 10 years,
the figure will be 37 in 1000 (i.e. an extra 5
cases).
• For women who start taking oestrogen plus
progestogen HRT at age 50 and take it for
5 years, the figure will be 38 in 1000 (i.e. an
extra 6 cases).
• If they take oestrogen plus progestogen HRT
for 10 years, the figure will be 51 in 1000 (i.e.
an extra 19 cases).
If you notice any changes in your breast,
such as:
• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel
Make an appointment to see your doctor as
soon as possible.

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Read all of this leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
• In this leaflet, Cyclo-Progynova 2 mg will be
called Cyclo-Progynova.
Information in this leaflet can be found by
looking under the following sections:
1.
What Cyclo-Progynova is for
1.1 Cyclo-Progynova is used for
2.
Before you take Cyclo-Progynova
2.1 Do not take Cyclo-Progynova if
2.2 Check with your doctor before taking CycloProgynova if
2.3 Safety of HRT
2.4 Heart disease
2.5 Stroke
2.6 Blood clots
2.7 Surgery (Surgical operations)
2.8 Breast cancer
2.9 Endometrial cancer
2.10 Ovarian cancer
2.11 Dementia
2.12 Tell your doctor if you are taking any of the
following medicines
2.13 Contraception
2.14 Pregnancy and breast-feeding
2.15 Driving and using machines
2.16 Warning about sugar intolerance
3.
How to take Cyclo-Progynova
3.1 When to start taking your medicine for the
first time
3.2 How to use the medicine
3.3 Medical check-ups
3.4 What bleeding pattern to expect with CycloProgynova
3.5 If you take more Cyclo-Progynova than you
should
3.6 If you forget to take Cyclo-Progynova
4.
Possible side effects
5.
How to store Cyclo-Progynova
6.
Further information.
6.1 What Cyclo-Progynova contains
6.2 What Cyclo-Progynova looks like
6.3 Marketing Authorisation Holder
6.4 Manufacturer

If the bleeding or spotting:
• carries on for more than the first few
months
• starts after you’ve been on HRT for a while
• carries on even after you’ve stopped taking
HRT.
You must make an appointment to see your
doctor. It could be a sign that your endometrium
has become thicker.

2.10 Ovarian cancer
Ovarian cancer (cancer of the ovaries) is very
rare, but it is serious. It can be difficult to
diagnose, because there are often no obvious
signs of the disease.
Some studies have indicated that taking
oestrogen-only HRT for more than 5 years may
increase the risk of ovarian cancer. It is not yet
known whether other kinds of HRT increase the
risk in the same way.

2.11 Dementia
HRT will not prevent memory loss. In one study
of women who started using combined HRT
after the age of 65, a small increase in the risk of
dementia was observed.

2.12 Liver tumor
During or after the use of hormones such as those
that are contained in Cyclo-Progynova, benign
liver tumors have rarely occurred, and malignant
liver tumors even more rarely. In isolated cases,
bleeding from such tumors into the abdominal
cavity has endangered life. Although such events
are extremely improbable you should inform your
doctor about any unusual feelings in your upper
abdomen that do not disappear within a short
time.

2.13 Tell your doctor if you are taking any of
the following medicines:
• Anticonvulsants such as phenobarbital or
phenytoin (to treat epilepsy)
• Antibiotics such as rifampicin or rifabutin (to
treat infections)
• Herbal medicines containing the herb St. John’s
Wort
• Insulin or other medicines to treat diabetes
• Protease inhibitors (to treat HIV)
• Transcriptase inhibitors such as nevirapine or
efavirenz (to treat HIV)
• Any other medicine, including medicines
obtained without a prescription.

2.14 Contraception
This medicine will not act as a contraceptive.
Ask your doctor for advice if you are already using
a contraceptive. This medicine may interfere with
it.

2.15 Pregnancy and breast-feeding
Do not take Cyclo-Progynova if you are pregnant
or breast-feeding.
If you become pregnant whilst taking this
medicine, you must immediately stop taking this
medicine and ask your doctor for advice.

2.16 Driving and using machines
Whilst taking Cyclo-Progynova you may feel dizzy.
If this happens, do not drive or operate machinery.

2.17 Warning about sugar intolerance
This medicine contains sugar. If you have been
told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking
this medicine.

3.

How to take Cyclo-Progynova

Always take Cyclo-Progynova exactly as your
doctor has told you.
Important:
Your doctor will choose the dose that is right
for you. Your dose will be shown clearly on
the label that your pharmacist puts on your
medicine. If it does not, or you are not sure, ask
your doctor or pharmacist.

3.1 When to start taking your medicine for
the first time
Depending on your situation you should start to
take this medicine at the following times of the
month:
• If you are having regular periods, start taking the
medicine on the fifth day of your period.
• If you are not having regular periods, you can
start at any time.
• If you are changing from another HRT medicine
that gives you a period complete the treatment
course of the other medicine. Then on the next
day start to take this medicine.
• If you are changing from another HRT medicine
that does not give you a period, you can start at
any time.

3.2 How to use the medicine
• Your pack contains 1 foil memo-strip and
7 blue stickers showing days of the week. Each
blue sticker starts with a different day of the
week.
• Peel off a strip that starts with your starting
day. Stick this sticker along the top of the foil
memostrip where it states ‘fix the blue sticker
here’ so that the first day is above the pill
marked ‘start’.
• You can now see on which days you have to
take each tablet. Take one tablet each day,
following the direction of the arrows, until you
have finished all 21 tablets.
• Swallow the tablets whole with water. Do not
chew the tablets.
• Take the tablets at the same time every day.
• After day 21 you will have a 7 day tablet free
break. During this week, bleeding similar to a
period may occur. This is normal.
• Start the next strip immediately after the 7 day
break. You will start your new strip of tablets on
the same day of each month. Take the tablets
even if your bleeding has not finished.
If you are not sure how to use the sticker and the
memo-pack then please ask your pharmacist for
advice.

3.3 Medical check-ups
Once you are taking this medicine:
• Regularly check your breasts for any changes.
If you notice dimpling of the skin, changes in
the nipple, or any lumps you must see your
doctor as soon as possible.
• Go for regular breast screening
• Go for regular cervical smear tests
• See your doctor for regular check-ups (at least
once a year). At these check-ups, your doctor
will discuss with you the benefits and risks of
continuing to take HRT.

3.5 If you take more Cyclo-Progynova than
you should
If you accidentally take too much of your
medicine, immediately tell your doctor or go to the
nearest hospital casualty department.

3.6 If you forget to take Cyclo-Progynova
• If your tablet is less than 12 hours late, take the
tablet as soon as possible, then take your next
tablet at the normal time.
• If your tablet is more than 12 hours late, leave
the forgotten tablet in the pack, and take your
next tablet at the normal time.
• You may get some vaginal bleeding
(breakthrough bleeding) if you have missed a
tablet. This is normal.
If you have any further questions about the use of
this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines Cyclo-Progynova can cause
side effects, although not everybody gets them.
If you have any of the following symptoms:
• Chest pain that spreads to your arm or
neck
• Sudden numbness or confusion
• Difficulty breathing
• Severe rash that might blister
• Sudden pain and swelling in your leg
• You notice yellowing of your skin or eyes
• Severe or prolonged headache, possibly
with disturbed vision for the first time.
Seek immediate medical help and stop
taking Cyclo-Progynova.
If you get any of the following symptoms:
• If you notice any changes in your breast
such as a lump, dimpling in the skin or the
nipple changing
• If bleeding or spotting carries on for more
than the first few months, or starts after
you have been taking the tablets for a
while
• If bleeding or spotting carries on even after
you’ve stopped taking HRT.
See your doctor as soon as possible.
Important: All the symptoms in the boxes above
are signs that you may be developing a serious
problem. If you ignore these symptoms they may
become worse.
Other possible side effects
The following symptoms, which may or may not
have been caused by hormone replacement
therapy, and which in some cases were probably
symptoms of the climacteric, have been reported
in users of different oral hormone replacement
therapy preparations:
Common undesirable effects (between 1 and 10
in every 100 users may be affected)
• weight loss or gain
• Headache
• stomach pain, nausea
• rash, itching
• vaginal bleeding including Spotting (bleeding
irregularities usually subside during continued
treatment)
Uncommon undesirable effects (between 1 and
10 persons in every 1,000 users may be affected)
• allergies (hypersensitivity reaction)
• depressed mood
• dizziness
• visual disturbances
• palpitations(irregular, rapid beating or pulsation
of the heart)
• dyspepsia (indigestion)
• erythema nodosum (reddish painful nodules),
• urticaria (hives)
• breast pain, breast tenderness
• edema(swelling due to excessive fluid retention)
Rare undesirable effects (between 1 and 10 in
every 10,000 users may be affected)
• anxiety, libido decreased or libido increased (an
increase or a decreased interest in sex)
• migraine
• contact lens intolerance
• bloating, vomiting
• hirsutism (excessive hair growth), acne
• muscle cramps
• dysmenorrhea (painful period), vaginal
discharge, Pre-menstrual-like syndrome,
swollen breast
• fatigue
In women with episodes of swelling in body parts
such as hands, feet, face, airway passages that
are caused by a defect in the gene that controls
a blood protein called C1-inhibitor (hereditary
angioedema) the hormone estradiol valerate
in Cyclo-Progynova may induce or exacerbate
symptoms of hereditary angioedema.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.

5.

How to store Cyclo-Progynova

Keep out of the reach and sight of children.
Do not use Cyclo-Progynova after the expiry date
on the carton. The expiry date refers to the last
day of that month.
Medicines should not be disposed of via
wastewater or household waste. Return any
medicine you no longer need to your pharmacist.

6.2 What Cyclo-Progynova looks like
Cyclo-Progynova is made up of white and pale
brown tablets.
Each carton contains 1 or 3 memo-packs. Each
memo-pack contains 21 tablets, which include
11 white tablets and 10 pale brown tablets.
Not all pack sizes may be marketed.

6.4 Manufacturer
Bayer Weimer GmbH und Co KG, Weimar,
Dobereinerstrasse 20D-99427, Germany and
Bayer Pharma AG, Berlin, Germany
This leaflet was last updated on November 2013
If this leaflet is difficult to see or read or you
would like it in a different format, please
contact Meda Pharmaceuticals Ltd, Skyway
House, Parsonage Road, Takeley, Bishop’s
Stortford, CM22 6PU.

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Bayer Pharma AG
code-no.: 666
country: GB/-/MEDA
PZ: 2599F-4

As with normal periods, the amount of blood loss
will vary from woman to woman.
Your bleeding pattern may change when you are
taking this medicine. You may have:
• Bleeding in the first three weeks of starting the
tablets. If so, ask your doctor for advice.
• Heavier bleeding. You may notice this more
if your periods have become short or lighter
before you started treatment. This is normal.
• Bleeding in the break where you take no tablets.
This is normal.
If after several months you are still getting
spotting or breakthrough bleeding, or you are
worried about your bleeding you must see your
doctor.

page 2

3.4 What bleeding pattern to expect with
Cyclo-Progynova

approval:

Taking oestrogen-only HRT for a long time
can increase the risk of cancer of the lining
of the womb (the endometrium). Taking a
progestogen as well as the oestrogen helps to
lower the extra risk.
If you still have your womb, your doctor will
usually prescribe a progestogen as well as
oestrogen. These may be prescribed separately,
or as a combined HRT product.
If you have had your womb removed (a
hysterectomy), your doctor will discuss with you
whether you can safely take oestrogen without a
progestogen.
If you’ve had your womb removed because
of endometriosis, any endometrium left in
your body may be at risk. So your doctor may
prescribe HRT that includes a progestogen as
well as an oestrogen.
Your product, Cyclo-Progynova contains a
progestogen.
Compare
• Looking at women who still have a uterus
and who are not taking HRT – on average 5
in 1000 will be diagnosed with endometrial
cancer between the ages of 50 and 65.
• For women who take oestrogen-only HRT,
the number will be 2 to 12 times higher,
depending on the dose and how long you take
it.
• The addition of a progestogen to oestrogenonly HRT substantially reduces the risk of
endometrial cancer.
If you get breakthrough bleeding or spotting,
it’s usually nothing to worry about, especially
during the first few months of taking HRT.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.